Opioid-use DisorderpCARENCT04675099
Promoting Caregiver-child Attachment and Recovery Through Early Intervention (pCARE): A Pilot Randomized Control Trial
A study testing pCARE and Standard Early Intervention services in people with Opioid-use Disorder and Substance Use Disorders, run by Baystate Medical Center at 1 site in United States.
Trial summary
This purpose of this study is to use the existing infrastructure and therapeutic relationships developed by Early Intervention, a national system of child development programs, to make an evidence-based intervention for parents with substance use disorder, Mothering from the Inside Out, more readily accessible to… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Opioid-use Disorder, Substance Use Disorders, Parenting
- What is being tested?
- pCARE and Standard Early Intervention services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- 18 years of age or older
- Mother to an index child between birth and 2 years old at the time of estimated start of intervention delivery
- Engaged in formal recovery supports (including but not limited to: Recovery Coaches, support groups specific to people in recovery, medication assisted treatment) at time of enrollment for a minimum 3 months
- Willing to receive parenting supports for the index child through EI
- Geographically based within the catchment area of participating EI programs
Who cannot join
- Severe mental health problems (suicidal, homicidal, psychosis episodes within the past year)
- Significant cognitive impairment (unable to give informed consent)
- Has an index child that has complex medical problems that significantly impact the child's ability to interact with the parent (e.g. blindness, deafness, severe weakness, or paralysis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01109
About this study
This purpose of this study is to use the existing infrastructure and therapeutic relationships developed by Early Intervention, a national system of child development programs, to make an evidence-based intervention for parents with substance use disorder, Mothering from the Inside Out, more readily accessible to postpartum women with substance use disorder. This study will assess the feasibility, acceptability, and preliminary outcomes of the intervention in a pilot randomized controlled trial. We will also identify key implementation domains that impact successful delivery. We hypothesize that the intervention will be feasible and acceptable to the study participants.
- Conditions
- Opioid-use Disorder, Substance Use Disorders, Parenting
- Being tested
- pCARE, Standard Early Intervention services
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pCAREBehavioural
Also called Mothering from the Inside Out
"Mothering from the Inside Out" is an evidence-based intervention delivered in substance use treatment settings that helps mothers with substance use disorders foster parent-child attachment, cope with stressful parenting situations, and promote their child's healthy development. This 3 month counseling intervention both improves parent-child attachment and decreases rates of drug relapse among mothers. The proposed mechanism of action targeted by the intervention is a change in parental reflective functioning, defined as the capacity to recognize and make sense of mental states (especially emotional states) and understand how they influence behavior and relationships.
Standard Early Intervention servicesOther
The state of Massachusetts provides voluntary early childhood development services to substance-exposed infants through a system of Early Intervention programs. These programs offer coordinated services to all infants and toddlers with disabilities and those at risk for developmental delays in homes and child centers beginning at birth.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard Early Intervention services Receives: Other: Standard Early Intervention services |
| Intervention | Experimental | pCARE Receives: Behavioral: pCARE; Other: Standard Early Intervention services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and enrollment
The number of mothers referred, approached, and enrolled in the study
Measured: Through study completion up to 3 months
Number of Early Intervention services received
All Early Intervention services received by mothers and their child(ren)
Measured: Through intervention period, an average of 6 months
The duration of intervention sessions
Session duration in minutes
Measured: Through intervention period, an average of 6 months
The number of intervention sessions completed by mothers
The total number of sessions completed
Measured: Through intervention period, an average of 6 months
Mothers' perceived barriers and facilitators to intervention delivery
Qualitative perceptions of intervention logistics
Measured: Through intervention period, an average of 6 months
The number of supervision sessions completed by providers
The total number of sessions completed
Measured: Through intervention period for each mother participant, an average of 6 months
Early Intervention and additional services received by mothers after intervention period
Services received qualitatively listed by mothers
Measured: Post-intervention up to 3 months
Retention of study participants
Time to loss of follow-up and perceived reason for discontinuation
Measured: Through study completion up to 3 months
Qualitative perceptions of intervention sessions from mothers
Open-ended feedback of intervention sessions
Measured: Through intervention period, an average of 6 months
Qualitative perceptions of intervention sessions from Early Intervention providers
Open-ended feedback of intervention sessions
Measured: Through intervention period for each mother participant, an average of 6 months
Qualitative perceptions of intervention sessions from Early Intervention providers after intervention period
Open-ended feedback via a 30-minute interview
Measured: Post-intervention for each mother participant up to 3 months
Qualitative perceptions of intervention sessions from mothers after intervention period
Open-ended feedback via a 30-minute interview
Measured: 3 months after the completion of the intervention
Adherence of providers to the intervention according to a revised 9-point "Mothering from the Inside Out" Adherence Rating Scale
The revised Mothering from the Inside Out (MIO) Adherence Rating Scale is a 9-item measure rated on a 3-point scale for frequency of occurrence (never or seldom, sporadically, or consistent) and competence (poorly executed, adequately executed, or well-executed) of intervention delivery. The measure uses intervention session audio- or video- recordings and includes MIO specific fidelity and a measure of therapeutic alliance.
Measured: Through intervention period for each mother participant, an average of 6 months
Secondary outcomes (2)
Changes in parental reflective functioning according to the Parent Development Interview (PDI)
The Parent Development Interview (PDI) is a 14-item measure of parental reflective functioning in an interview format. Audio-recorded interviews are transcribed and coded on a 9-point Likert scale.
Measured: 0, 3, and 6 months
Changes in parent-child interactions according to the Coding Interactive Behavior (CIB) manual
Conducting a Free Play Session (a 10 minute video-recorded and coded interaction, face-to-face interaction (infants) or play session) and analyzing using 5-point Likert scale and the Coding Interactive Behavior (CIB) manual, a global coding system with 43 items (22 parent, 16 infant, and 5 dyadic codes). There are six composite scales for: maternal sensitivity, maternal intrusiveness, child involvement, child negative emotionality, dyadic reciprocity and dyadic negative states; and two additional constructs for 12-36 month olds: maternal limit setting and child compliance.
Measured: 0, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start18 Dec 2020
- Primary completion30 Apr 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Peacock-Chambers, MD, Baystate Medical Center
- Investigators
- Elizabeth Peacock-Chambers, MD, MSc, Principal investigator, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675099
- Sponsor's protocol ID
- BH-20-132
- Acronym
- pCARE
- Status last verified
- Aug 2024
- First submitted
- 18 Nov 2020
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Caregiver-child Attachment and Recovery Through Early Intervention (pCARE): A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04675099
- Acronym / sponsor ID
- pCARE / BH-20-132
- Conditions
- Opioid-use Disorder, Substance Use Disorders, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to use the existing infrastructure and therapeutic relationships developed by Early Intervention, a national system of child development programs, to make an evidence-based intervention for parents with substance use disorder, Mothering from the Inside Out, more readily accessible to postpartum women with substance use disorder. This study will assess the feasibility, acceptability, and preliminary outcomes of the intervention in a pilot randomized controlled trial. We will also identify key implementation domains that impact successful delivery. We hypothesize that the intervention will be feasible and acceptable to the study participants.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Standard Early Intervention servicesStandard Early Intervention services |
| Intervention | Experimental | Behavioral: pCARE, Other: Standard Early Intervention servicespCARE |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- English speaking
- 18 years of age or older
- Mother to an index child between birth and 2 years old at the time of estimated start of intervention delivery
- Engaged in formal recovery supports (including but not limited to: Recovery Coaches, support groups specific to people in recovery, medication assisted treatment) at time of enrollment for a minimum 3 months
- Willing to receive parenting supports for the index child through EI
Key exclusion criteria (3 listed)
- Severe mental health problems (suicidal, homicidal, psychosis episodes within the past year)
- Significant cognitive impairment (unable to give informed consent)
- Has an index child that has complex medical problems that significantly impact the child's ability to interact with the parent (e.g. blindness, deafness, severe weakness, or paralysis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pCAREAlso: Mothering from the Inside Out"Mothering from the Inside Out" is an evidence-based intervention delivered in substance use treatment settings that helps mothers with substance use disorders foster parent-child attachment, cope with stressful parenting situations, and promote their child's healthy development. This 3 month counseling intervention both improves parent-child attachment and decreases rates of drug relapse among mothers. The proposed mechanism of action targeted by the intervention is a change in parental reflective functioning, defined as the capacity to recognize and make sense of mental states (especially emotional states) and understand how they influence behavior and relationships. | Behavioural | Intervention |
| Standard Early Intervention servicesThe state of Massachusetts provides voluntary early childhood development services to substance-exposed infants through a system of Early Intervention programs. These programs offer coordinated services to all infants and toddlers with disabilities and those at risk for developmental delays in homes and child centers beginning at birth. | Other | Control, Intervention |
Primary outcome
Recruitment and enrollment
Time frame: Through study completion up to 3 months
The number of mothers referred, approached, and enrolled in the study
Number of Early Intervention services received
Time frame: Through intervention period, an average of 6 months
All Early Intervention services received by mothers and their child(ren)
The duration of intervention sessions
Time frame: Through intervention period, an average of 6 months
Session duration in minutes
The number of intervention sessions completed by mothers
Time frame: Through intervention period, an average of 6 months
The total number of sessions completed
Mothers' perceived barriers and facilitators to intervention delivery
Time frame: Through intervention period, an average of 6 months
Qualitative perceptions of intervention logistics
The number of supervision sessions completed by providers
Time frame: Through intervention period for each mother participant, an average of 6 months
The total number of sessions completed
Early Intervention and additional services received by mothers after intervention period
Time frame: Post-intervention up to 3 months
Services received qualitatively listed by mothers
Retention of study participants
Time frame: Through study completion up to 3 months
Time to loss of follow-up and perceived reason for discontinuation
Qualitative perceptions of intervention sessions from mothers
Time frame: Through intervention period, an average of 6 months
Open-ended feedback of intervention sessions
Qualitative perceptions of intervention sessions from Early Intervention providers
Time frame: Through intervention period for each mother participant, an average of 6 months
Open-ended feedback of intervention sessions
Qualitative perceptions of intervention sessions from Early Intervention providers after intervention period
Time frame: Post-intervention for each mother participant up to 3 months
Open-ended feedback via a 30-minute interview
Qualitative perceptions of intervention sessions from mothers after intervention period
Time frame: 3 months after the completion of the intervention
Open-ended feedback via a 30-minute interview
Adherence of providers to the intervention according to a revised 9-point "Mothering from the Inside Out" Adherence Rating Scale
Time frame: Through intervention period for each mother participant, an average of 6 months
The revised Mothering from the Inside Out (MIO) Adherence Rating Scale is a 9-item measure rated on a 3-point scale for frequency of occurrence (never or seldom, sporadically, or consistent) and competence (poorly executed, adequately executed, or well-executed) of intervention delivery. The measure uses intervention session audio- or video- recordings and includes MIO specific fidelity and a measure of therapeutic alliance.
2 secondary outcomes
Changes in parental reflective functioning according to the Parent Development Interview (PDI)
Time frame: 0, 3, and 6 months
Changes in parent-child interactions according to the Coding Interactive Behavior (CIB) manual
Time frame: 0, 3, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Peacock-Chambers, MD, MSc principal investigator
Baystate Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pCARE and Standard Early Intervention services in people with Opioid-use Disorder and Substance Use Disorders, run by Baystate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and enrollment (time frame: Through study completion up to 3 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.